Meropenem 1 g powder for solution for injection or infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Meropenem Trihydrate

Available from:

Rowex Ltd

ATC code:

J01DH02

INN (International Name):

Meropenem Trihydrate

Pharmaceutical form:

Powder for solution for injection/infusion

Therapeutic area:

meropenem

Authorization status:

Not marketed

Authorization date:

2023-07-28

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MEROPENEM 500 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION
MEROPENEM 1 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION
meropenem
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Meropenem is and what it is used for
2.
What you need to know before you use Meropenem
3.
How to use Meropenem
4.
Possible side effects
5.
How to store Meropenem
6.
Contents of the pack and other information
1.
WHAT MEROPENEM IS AND WHAT IT IS USED FOR
Meropenem contains the active substance meropenem and belongs to a
group of medicines called
carbapenem antibiotics. It works by killing bacteria, which can cause
serious infections.
Meropenem is used to treat the following in adults and children aged 3
months and older:

Infection affecting the lungs (pneumonia)

Lung and bronchial infections in patients suffering from cystic
fibrosis

Complicated urinary tract infections

Complicated infections in the abdomen

Infections that you can catch during or after the delivery

Complicated skin and soft tissue infections

Acute bacterial infection of the brain (meningitis).
Meropenem may be used in the management of neutropenic patients with
fever that is suspected to be due to
a bacterial infection.
Meropenem may be used to treat bacterial infection of the blood which
might be associated with a type of
infection mentioned above.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MEROPENEM
DO NOT USE MEROPENEM IF:

you are allergic to meropenem or a

Summary of Product characteristics

Health Products Regulatory Authority
31 July 2023
CRN00C3G5
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Meropenem 1 g powder for solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1140.8 mg of meropenem trihydrate equivalent to
1000 mg anhydrous meropenem.
Excipient with known effect
Each 1000 mg vial contains 90 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
A white to light yellow crystalline powder.
Osmolality of 275-441 mOSm/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Meropenem is indicated for the treatment of the following infections
in adults and children aged 3 months and older (see
sections 4.4 and 5.1):

Severe pneumonia, including hospital and ventilator-associated
pneumonia

Broncho-pulmonary infections in cystic fibrosis

Complicated urinary tract infections

Complicated intra-abdominal infections

Intra- and post-partum infections

Complicated skin and soft tissue infections

Acute bacterial meningitis
Meropenem may be used in the management of neutropenic patients with
fever that is suspected to be due to a bacterial
infection.
Treatment of patients with bacteraemia that occurs in association
with, or is suspected to be associated with, any of the
infections listed above.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The tables below provide general recommendations for dosing.
The dose of meropenem administered and the duration of treatment
should take into account the type of infection to be
treated, including its severity, and the clinical response.
A dose of up to 2000 mg three times daily in adults and adolescents
and a dose of up to 40 mg/kg three times daily in
children may be particularly appropriate when treating some types of
infections, such as infections due to less susceptible
bacterial species